Catalog Number

-

Brand Name

LUMISCOPE

Version/Model Number

6700

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

cfd3c921-803d-4fdd-bdbd-7b74f582e7ab

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

M36867003

Quantity per Package

8

Contains DI Package

M36867002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-